YY 1001-2024 PDF English (YY 1001.1-2004: Older version)
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Glass syringes - Part 1: Syringes with all-glass
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YY 1001-2024: PDF in English YY1001-2024
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.20
CCS C 31
YY 1001-2024
Replacing YY 1001.1-2004, YY1001.2-2004
Glass syringes
全玻璃注射器
ISSUED ON: FEBRUARY 07, 2024
IMPLEMENTED ON: MARCH 01, 2026
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Structural form ... 6
5 Materials ... 7
6 Requirements and test methods ... 7
7 Marking ... 11
8 Packaging ... 12
9 Transportation and storage ... 12
Annex A (normative) Test methods for capacity tolerance, durability of graduation lines
and metering numbers ... 13
Annex B (informative) Syringe cleanliness ... 14
Bibliography ... 15
Foreword
This document was drafted in accordance with the provisions of GB/T 1.1-2020
“Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents”.
This document replaces YY 1001.1-2004 “Glass syringes - Part 1: Syringes with all-
glass” and YY 1001.2-2004 “Glass syringes - Part 2: Blue syringes with all-glass”.
Compared with YY 1001.1-2004 and YY 1001.2-2004, in addition to structural
adjustments and editorial changes, the main technical changes are as follows:
- ADD barrel flange (see Figure 1, 6.17 of this document);
- DELETE “Matching code” (see 5.12 of the 2004 edition);
- DELETE “Inspection rules” (see Clause 7 of the 2004 edition);
- DELETE “Instructions for use” (see 8.2 of the 2004 edition).
Attention is drawn to the possibility that some of the elements of this document may be
the subject of patent rights. The issuing authority of this document shall not be held
responsible for identifying any or all such patent rights.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee on Medical
Syringes (Needles) of Standardization Administration of China (SAC/TC 95).
The previous released versions replaced by this document are as follows:
- YY 1001.1, first published in 1999 as YY 91001-1999, first revised in 2004 as YY
1001.1-2004;
- YY 1001.2, first published in 1999 as YY 91061-1999, first revised in 2004 as YY
1001.2-2004.
Glass syringes
1 Scope
This document specifies the structural type, materials, requirements, marking,
packaging, transportation and storage of glass syringes and blue syringes with all-glass
(hereinafter referred to as “syringes”), and describes the corresponding test methods.
This document applies to glass syringes and blue syringes with all-glass. After the
product is equipped with an injection needle, it is used for subcutaneous, intramuscular,
and intravenous injection of liquid and extraction of liquid.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 1962.1 Conical fittings with a 6 % (Luer) taper for syringes, needles and
certain other medical equipment - Part 1: General requirement
YY 91017 Test method of leakage between barrel and plunger of medical glass
syringes
3 Terms and definitions
For the purpose of this document, the following terms and definitions apply.
3.1
glass syringes
Medical syringes of which the barrel, plunger and hub are all made of borosilicate
aluminum glass material and can be reused after sterilization.
3.2
blue syringes with all-glass
Syringes of which the barrel, plunger and hub are all made of borosilicate aluminum
glass material (the plunger is blue solid) and can be reused after sterilization.
3.3
The syringe barrel and plunger are cleaned and assembled in a wet condition, then the
plunger is pushed, pulled and rotated in the barrel. The barrel and plunger shall be easy
to assemble and disassemble. After matching, they shall have good sliding performance
and shall not get stuck.
6.10 Hub tightness
The syringe hub shall fit tightly with the injection needle. Suck 1/4 of the capacity of
water into the syringe, then clean and dry the syringe hub and the standard fitting cone
hole that meets the requirements of GB/T 1962.1 and tighten them, put the syringe flat
on the tightness tester, and pass the specified water pressure value from the barrel fitting.
When subjected to a water pressure of 300 kPa, no water shall drip within 30 s.
6.11 Thermal shock resistance
The syringes shall be able to resist thermal shock. Disassemble the syringe barrel and
plunger, place them vertically in the cleaning device with the hub facing upward,
immerse them in water at a temperature of 20 ℃, and then put them in boiling water
(the water temperature shall not drop by more than 2 ℃ at this time), boil for 5 min,
and then quickly put the cleaning device back into the water at 20 ℃ (the water
temperature shall not rise by more than 2 ℃ at this time), take out the cleaning device,
and observe the syringe with your eyes, there shall be no burst.
6.12 Stress
The syringes shall be well annealed. When observed in a polarizing stress meter, the
internal stress shall be orange-red at the lowest.
6.13 Residual liquid volume in syringe
Suck water into the dry syringe to the nominal capacity, then remove the air, push the
plunger to the bottom of the barrel and pull it out, so that the water on the plunger and
the barrel wall can fully circulate and concentrate at the bottom of the barrel; use a
syringe of appropriate specifications (0.25 mL, 1 mL, 2 mL) with a long injection
needle, completely absorb the water remaining in the barrel (including the hub hole),
and then read the value as the residual liquid volume. The residual liquid volume of the
syringe shall not exceed the requirements of Table 6.
c) batch number or production date.
7.2 Shelf or multi-unit packaging
Shelf packaging or multi-unit packaging (if used) shall be marked with at least the
following information:
a) name and address of manufacturer and/or distributor;
b) product name, model, specifications;
c) batch number or production date;
d) product quantity;
e) recommended storage conditions (if any);
f) information on product sterilization methods provided by the manufacturer;
g) requirements or marks for handling and transportation.
8 Packaging
8.1 The packaged syringes shall be clean and dry, and soft padding shall be placed in
the barrel. The packaging box shall have cushion to prevent the syringe from loosening
or hitting to prevent damage to the syringe.
8.2 There shall be no foreign matter in the package.
9 Transportation and storage
9.1 The syringes shall be protected from heavy pressure, direct sunlight, rain and snow
during transportation.
9.2 The syringes shall be stored in a clean environment without corrosive gases and
with good ventilation.
9.3 Handle with care during transportation, rolling and throwing are strictly prohibited.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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